Modular catheter system

ABSTRACT

A modular catheter system. The modular catheter system may include a first tubular member, a first catheter tubing, a second tubular member, a second catheter tubing and a plurality of concentric seals. The first catheter tubing may be disposed within an interior portion of the first tubular member while the second catheter tubing may be disposed within an interior portion of the second tubular member. The first tubular member and the second tubular member are removably attachable to each other. The plurality of concentric seals may encircling the first catheter tubing and the second catheter tubing, and the first catheter tubing and the second catheter tubing form a continuous path when the first tubular member and the second tubular member are removably attached to each other. The catheter system may also be formed as a dual lumen catheter.

BACKGROUND

1. Field of the Invention

Embodiments of the present invention relate to catheter technology and,in particular, to modular catheter systems having removable catheterportions.

2. Description of Related Art

The use of implantable devices to remedy medical conditions is becomingincreasingly frequent as the size and cost of such devices shrinks andas the devices become easier to use. Many patients who, in the past,were forced to make routine visits to a medical professional fortreatment or analysis or who were forced to self-administer treatmentnow rely on implanted devices to treat and analyze various medicalconditions, thereby alleviating or eliminating the burden of trips tothe hospital or doctor's office and the physical and emotionaldifficulty of rendering treatment to oneself. The use of implantabledevices has given many patients the freedom they once new before theonset of their medical conditions, or perhaps the freedom they've neverknown for those who have dealt with medical conditions their entirelives.

For example, many people with diabetes now rely on implanted infusionpumps to deliver insulin. Implanted infusion pumps, along withassociated sensing and control electronics, are capable of determiningan amount of insulin required by a patient and can deliver a bolus orbasal rate of insulin. Frequent manual testing of blood glucose levelshas been replaced by glucose sensing technology included with the pump.Also, the routine injection of insulin by the patient using a needle hasbeen replaced by the internal delivery of insulin by the pump based onthe glucose levels determined by the sensor. Accordingly, diabeticpatients who have taken advantage of implanted infusion pumps enjoy alifestyle similar to that enjoyed by non-diabetics.

Most implanted devices include catheters for a variety of reasons. Forexample, implanted catheters may be used to deliver an infusant, such asa drug or other medicant, or may be used to provide a path for sensingtechnology or electronic signals. Currently, many catheters used inconjunction with implantable devices, such as an implantable infusionpump, for example, typically connect directly to the implantable device,as can be seen in the pump-catheter system 2 shown in FIG. 1. In FIG. 1,a catheter 8 is a right-angled catheter that makes a direct connectioninto an implantable infusion pump 4 at a connection point 6. When thecatheter 8 needs to be replaced, the entire catheter 8 is removed at theconnection point 6. Although connecting the catheter directly to theimplantable device appears to be a logical, simple way to make aconnection to the device, in practice, such a connection can actually beinefficient and even detrimental to a patient.

For example, if an implantable pump is placed into a patient, a pocketof tissue, i.e., a “pump pocket,” forms around the pump and,consequently, the interface between the pump and the catheter as well.Generally, if the catheter includes a sensor, the catheter will needreplacement more often than the pump needs to be replaced or needs to beserviced. To replace the catheter, then, requires that the pump pocketbe opened, a procedure that is time consuming and undesirable. Once apump pocket forms, opening it may be traumatic for the patient, timeconsuming for both patient and doctor, expensive and can increase therisk of infection. Also, opening a pump pocket requires a hospital stayfor the procedure and for observation. Thus, although connecting acatheter directly to an implantable device appears reasonable, aconnection of this type is actually fraught with ramifications that worktoward the detriment of the patient and the patient's care providers.

In addition, many catheters made today that are suitable forimplantation are labor intensive from a manufacturing standpoint andcostly from a sterilization standpoint. For example, catheters that areused in complex applications can themselves be complex devices requiringsophisticated, expensive parts. Moreover, many of these parts aresensitive, such as the polyethylene tubing used in some catheters, andmust be sterilized using a sensitive technique such as EtOsterilization, for example. In order for implantable devices to beconsidered a routine prescription for the remedying of debilitatingmedical conditions, the catheters used in conjunction with such devicesmust themselves be manufacturing friendly and must interface with theimplantable devices in such a way catheter replacement is not a risky,expensive time consuming procedure.

SUMMARY

It is therefore an object of embodiments of the present invention toprovide a catheter system that is suitable for implantation into a humanbody. It is a further object of embodiments of the present invention toprovide a catheter system that is manufacturing friendly and can beproduced inexpensively relative to currently manufactured catheters. Itis yet a further object of embodiments of the present invention toprovide a catheter system that can be sterilized using simple,inexpensive sterilization techniques. It is yet a further object ofembodiments of the present invention to provide a modular cathetersystem and a catheter system having concentric seals that facilitatescatheter replacement without having to access pump pockets.

According to embodiments of the present invention, a catheter system mayinclude a first tubular member; a first catheter tubing, the firstcatheter tubing disposed within an interior portion of the first tubularmember; a second tubular member, the second tubular member beingremovably attachable to the first tubular member; a second cathetertubing, the second catheter tubing disposed within an interior portionof the second tubular member; and a plurality of concentric sealsencircling the first catheter tubing and the second catheter tubing. Thefirst catheter tubing and the second catheter tubing may form acontinuous path when the first tubular member may be removably attachedto the second tubular member. At least one of the plurality ofconcentric seals may be formed when the second tubular member isremovably attached to the first tubular member.

The first tubular member may form an angle with the second tubularmember when the second tubular member is removably attached to the firsttubular member. The angle formed between the first tubular member andthe second tubular member may be substantially a right angle.

The catheter system may further include a third catheter tubing, thethird catheter tubing disposed within an interior portion of the firsttubular member and adjacent the first catheter tubing; and a fourthcatheter tubing, the fourth catheter tubing disposed within an interiorportion of the second tubular member and adjacent the second cathetertubing. The third catheter tubing and the fourth catheter tubing mayform a path or a continuous path when the second tubular member isremovably attached to the first tubular member. The first cathetertubing may be concentric with the third catheter tubing and the secondcatheter tubing may be concentric with the fourth catheter tubing. Atleast one of the plurality of concentric seals formed when the secondtubular member is removably attached to the first tubular memberencircles the third catheter tubing and the fourth catheter tubing.

The first tubular member may include an extrusion and the second tubularmember may include a recess. The extrusion of the first tubular membermay fit into the recess of the second tubular member via friction.

The first catheter tubing may be a fluoropolymer. At least one of theplurality of concentric seals may be titanium. At least one titaniumconcentric seal may abut and encircle the fluoropolymer first cathetertubing. The first tubular member and the second tubular member may besilicone. The silicone first tubular member and the silicone secondtubular member may abut and encircle at least one titanium concentricseal.

The catheter system may further include an anchoring portion at aproximal end of the second tubular member. The proximal end of the firsttubular member may abut the anchoring portion of the second tubularmember when the first tubular member is removably attached to the secondtubular member.

Also, the catheter system may further include a coupling disposed at adistal end of the first tubular member. The coupling may be attachableto an implantable device, and the second catheter tubing may extend outof the second tubular member. The catheter system may further include asensor disposed within an interior portion of the second tubular member.

According to embodiments of the present invention, an implantablecatheter may include a housing, the housing having a removablyattachable interface; a first tubing, the first tubing disposed withinan interior portion of the housing; and a plurality of concentric sealsdisposed within the housing and encircling the first tubing. At leastone of the plurality of concentric seals may be formed when theremovably attachable interface is engaged by a peripheral device.

The implantable catheter may further include a second tubing disposedwithin an interior portion of the housing and adjacent the first tubing.The first tubing and the second tubing may be concentric. The firsttubing may be a fluoropolymer. The at least one of the plurality ofconcentric seals may be titanium. The at least one titanium concentricseal may abut and encircle the fluoropolymer first tubing. The housingmay abut and encircle the at least one titanium concentric seal. Thehousing may be plastic or silicone.

A method of implementing a catheter includes providing a first outerhousing; providing at least one first lumen tubing, the at least onefirst lumen tubing being disposed within an interior portion of thefirst outer housing; sealing the at least one first lumen tubing with afirst seal; and sealing the at least one first lumen tubing with asecond seal. The first seal and the second seal may be concentric andthe first seal and the second seal may encircle the at least one firstlumen tubing.

The method may further include providing a second housing and providingat least one second lumen tubing. The second housing may be removablyattachable to the first housing and the at least one second lumen tubingmay form a path or a continuous path with the at least one first lumentubing when the second housing is removably attached to the first lumenhousing. At least one of the first seal and the second seal may beformed when the second housing is removably attached to the firsthousing.

The method may further include providing at least one third lumen tubingadjacent the at least one first lumen tubing and providing at least onefourth lumen tubing adjacent the at least one second lumen tubing. Theat least one third lumen tubing may be concentric with the at least onefirst lumen tubing and the at least one fourth lumen tubing may beconcentric with the at least one second lumen tubing.

Other features and advantages of the invention will become apparent fromthe following detailed description, taken in conjunction with theaccompanying drawings which illustrate, by way of example, variousfeatures of embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

A detailed description of embodiments of the invention will be made withreference to the accompanying drawings, wherein like numerals designatecorresponding parts in the several figures.

FIG. 1 shows a side view of a catheter system according to the priorart.

FIG. 2 shows a generalized block diagram of a modular catheter systemaccording to an embodiment of the present invention.

FIG. 3 shows an implantable system using a modular catheter systemaccording to an embodiment of the invention.

FIG. 4 shows a modular catheter system according to an embodiment of thepresent invention.

FIG. 5 shows a perspective, isolated view of a member of a modularcatheter system according to an embodiment of the present invention.

FIG. 6 shows a perspective, isolated view of a member of a modularcatheter system according to an embodiment of the present invention.

FIG. 7 shows a cutaway perspective view of a member of a modularcatheter system according to an embodiment of the present invention.

FIG. 8 shows a cutaway side view of a member of a modular cathetersystem according to an embodiment of the present invention.

FIG. 9 shows a cutaway view of an anchoring mechanism for a modularcatheter system according to an embodiment of the present invention

FIG. 10 shows a perspective, cutaway view of an interface between afirst tubular member and a second tubular member of a modular cathetersystem according to an embodiment of the present invention.

FIG. 11 shows a cutaway view of a compression-fit interface between afirst tubular member and a second tubular member of a modular cathetersystem according to an embodiment of the present invention.

FIG. 12 shows a perspective, cutaway view of compression-fit interfacebetween a first tubular member and a second tubular member of a modularcatheter system according to an embodiment of the present invention.

DETAILED DESCRIPTION

In the following description of preferred embodiments, reference is madeto the accompanying drawings which form a part hereof, and in which areshown by way of illustration specific embodiments in which the inventionmay be practiced. It is to be understood that other embodiments may beutilized and structural changes may be made without departing from thescope of the preferred embodiments of the present invention.

The following description is directed primarily toward modular cathetersystems and catheters having concentric seals; however, embodiments ofthe present invention may be implemented in a variety of ways and may beused in a variety of capacities and applications. For example,embodiments of the present invention may be used for implantableinfusion pumps. Also, embodiments of the present invention may be usedin vivo or may be used percutaneously. Generally, embodiments of thepresent invention may be adapted for use in any environment in whichcatheter replacement without having to access a pump pocket is desiredor isolation of a catheter from its external environment is required.

FIG. 2 shows a generalized block diagram of a modular catheter system 10according to an embodiment of the present invention. In the embodimentof the invention shown in FIG. 2, individual components of the modularcatheter system 10 are modularized for ease of manufacturing and ease ofreplacement. The modular catheter system 10 shown in FIG. 2 includes,but is not limited to, a first tubular member 16, a junction 18 and asecond tubular member 20. The individual components may be formed as aplurality of male-female pairs. For example, the modular catheter system10 may be used in conjunction with an implantable device such as animplantable infusion pump 12. The implantable infusion pump 12 shown inFIG. 2 includes a female connection point 14. Accordingly, the firsttubular member 16 may be formed to have two male catheter tubing ends, afirst catheter tubing end of which interfaces with and connects to thefemale connection point 14, as shown. The second catheter tubing end 17of the first tubular member 16 may interface with the junction 18.

Likewise, the second tubular member 20 may include a first male cathetertubing end 21 and a second male catheter tubing end 22. The junction 18includes, but is not limited to, female connection points 19 into whichthe second catheter tubing end 17 of the first tubular member 16 and thefirst catheter tubing end 21 of the second tubular member 20 may beinserted. The second catheter tubing end 22 of the second tubular member20 may be left unattached, thereby allowing a fluid such as insulin orother drug or medicant to be dispersed into its surround area.

Although the embodiment of the invention shown in FIG. 2 shows the firsttubular member 16 and the second tubular member 20 having male ends andthe junction 18 having female ports, a variety of male-femalecombinations may be used. For example, the first tubular member 16 andthe second tubular member 20 may have female ports and the junction 18may have male connectors. Also, the junction 18 may be independent ofthe first tubular member 16 and the second tubular member 20 or may beintegrated into the first tubular member 16 and the second tubularmember 20.

By manufacturing the modular catheter system 10 as shown in theembodiment of the invention in FIG. 2, the modular catheter system 10may be made relatively inexpensively and with high reliability. Themodularization of components results in high volume production whilereducing costs. In addition, the manufacturing repeatability associatedwith modularization reduces product defects and increases reliability.

Also, the modular catheter system 10 facilitates catheter replacementafter the modular catheter system 10 has been implanted into a patient.For example, in the embodiment of the invention shown in FIG. 2, twojoints forming a right angle exist at the interface between the firsttubular member 16 and the junction 18 and the second tubular member 20and the junction 18. Because of the modularity of the modular cathetersystem 10, the first tubular member or the second tubular member may beremoved at a joint, i.e., at the interface between one of the tubularmembers and the junction 18. without removing the other tubular member.Accordingly, tubular member replacement is facilitated. Thus, if, forexample, the second tubular member 20 needs replacement, it may beremoved from the junction 18 while the remainder of the modular cathetersystem 10 remains intact and in place. If a pump or other device towhich the modular catheter system 10 is attached is surrounded by apocket of tissue, the tissue need not be disturbed in order to replace acomponent of the modular catheter system 10.

FIG. 3 shows an implantable system 30 using a modular catheter system 35according to an embodiment of the invention. In the embodiment of theinvention shown in FIG. 3, the modular catheter system 35 includes, butis not limited to, a first tubular member 36 and a second tubular member38. The first tubular member 36 interfaces and connects to animplantable device 32 at a connection point 34. The second tubularmember 38 may include other elements, such as a sensor, for example. Thefirst tubular member 36 and the second tubular member 38 may beremovably attached to each other at a junction 40. A catheter tubing 42extends out of the second tubular member 38 such that fluids may bereleased into the body. In addition, a sensor and associated componentsmay be located within the catheter tubing 42.

The entire implantable system 30 may be implanted in a human body.According to one embodiment of the invention, after implantation, apocket of tissue may form over the implantable device 32, the connectionpoint 34 and a portion of the first tubular member 36. Over time, suchas every one to two years, for example, a sensor disposed within thesecond tubular member 38 may need to be replaced or re-calibrated, thusrequiring removal from the implantation point. In addition, over time,the tip of the catheter tubing 32 may become obstructed due toparticulate build-up or other obstructions. When it becomes necessary toreplace the sensor or the tip of the catheter tubing, the second tubularmember 38 may be removed from the first tubular member 36. The firsttubular member 36 need not be removed from the connection point 34.

According to the embodiment of the invention shown in FIG. 3, the pocketof tissue formed over the implantable device 32, the connection point 34and a portion of the first tubular member 36 need not be opened. Becausethe modular catheter system 35 has been designed and fabricated in amodular fashion and because the first tubular member 36 may be removablyattached to the second tubular member 38, the pocket of tissue mayremain intact, thereby reducing the risk of infection. Moreover, thesecond tubular member 38 may be easily replaced with another unit in aminimally invasive fashion, thereby reducing the amount and severity oftrauma to the patient.

FIG. 4 shows a modular catheter system 50 according to an embodiment ofthe present invention. The modular catheter system 50 includes, but isnot limited to, a first tubular member 52 and a second tubular member54. In the embodiment of the invention shown in FIG. 4, the firsttubular member 52 and the second tubular member 54 are removablyattachable to each other. Thus, the modular catheter system 50 may beconfigured as a multi-member device. In the embodiment of the inventionshown in FIG. 4, the modular catheter system 50 is configured as atwo-member device. However, embodiments of the invention are not limitedto two parts, and may be configured from three or more members. Inaddition, in the embodiment of the invention shown in FIG. 4, an anglewhich is substantially a right angle is formed when the first tubularmember 52 and the second tubular member 54 are removably attached to oneanother.

The first tubular member 52 includes, but is not limited to, a coupling56, a first outer housing 58 and a first header portion 60. Alsoincluded with the first tubular member 52 is a loop assembly 70 whichmay be used to hold or grip the modular catheter system 50 or the firsttubular member 52 if necessary.

The second tubular member 54 includes, but is not limited to, a disc 52,a second header portion 54, a second outer housing 56 and a secondcatheter tubing 68. The first tubular member 52 and the second tubularmember 54 may be made from bio-compatible, bio-stable materials. Forexample, the coupling 56, first outer housing 58, first header portion60 and loop assembly 70 of the first tubular member 52 and the disc 62,second header portion 64, and second outer housing 66 of the secondtubular member 54 may be made from silicone rubber or polyethylene.

The coupling 56 at a distal end of the first tubular member 52 may bedesigned to interface with an implantable device. For example, if themodular catheter system 50 shown in the embodiment of FIG. 4 weredesigned for use with an implantable infusion pump used to deliverinsulin to diabetics, the coupling 56 could connect to a port on theimplantable infusion pump.

The second catheter tubing 68 at a distal end of the second tubularmember 54 may be located at a desirable position within the body of apatient, such as a patient's abdomen, for example. Insulin maintainedwithin the implantable infusion pump may exit the pump and travelthrough the first tubular member 52 and the second tubular member 54,exiting through the second catheter tubing 68 into the patient.

The disc 62 at a proximal end of the second tubular member 54 may beformed to provided an anchor point for the first header portion 60 ofthe first tubular member 52. In addition, the disc 62 provides a pointof leverage for a medical professional when removing the second tubularmember 54 from the first tubular member 52, as will be explained in moredetail below.

FIG. 5 shows a perspective, isolated view of the second tubular member54 according to an embodiment of the present invention. In addition tothe disc 62, the second header portion 64, the second outer housing 66and the second catheter tubing 68, FIG. 5 also shows a second sealmolding 72. The second seal molding 72 engages and forms a connectionwith the first tubular member 52 as will be explained in greater detailbelow.

FIG. 6 shows a perspective, isolated view of the first tubular member 52according to an embodiment of the present invention. In addition to thecoupling 56, the first outer housing 58 and the first header portion 60,FIG. 6 shows an extrusion 74. The extrusion 74 of the first tubularmember 52 interfaces and forms a connection with the second seal molding72 of the second tubular member 54, as will be explained in greaterdetail below.

FIG. 7 shows a cutaway perspective view of the second tubular member 54.According to the embodiment of the invention shown in FIG. 7, the secondcatheter tubing 68 includes, but is not limited to, a second outer lumen80 and a second inner lumen 82. The second outer lumen 80 and the secondinner lumen 82 extend the entire length of the second tubular member 54and terminate at the end of the extrusion 74. In the embodiment of theinvention shown in FIG. 7, the second outer lumen 80 and the secondinner lumen 82 are concentric. A dual lumen catheter of the type shownin FIG. 7 is disclosed in U.S. patent application Ser. No. 10/036,081,filed Dec. 28, 2002, the contents of which are hereby incorporated byreference herein. However, the second catheter tubing 68 is not limitedto the dual, concentric second outer lumen 80 and second inner lumen 82shown in the embodiment of the invention in FIG. 7. The second cathetertubing 68 may comprise a single lumen or may comprise two or morelumens. Moreover, if the second catheter tubing 68 comprises two or morelumens, the lumens may be concentric or may be positioned otherwiseadjacent to each other. For example, if the second catheter tubing 68comprises two lumens, the lumens may be positioned side-by-side or havesome other configuration advantageous to the application for which thecatheter is being used.

Also shown in the embodiment of the invention in FIG. 7 is a first sealmolding 84 and a second seal recess 86. The first seal molding 84 may beformed around the second catheter tubing 68 during manufacturing and maycompletely encircle the second catheter tubing 68. Thus, the first sealmolding 84 may provide a first seal for the second catheter tubing 68.The first seal molding 84 may be made from a variety of bio-compatible,bio-stable, implantable grade materials. For example, according to anembodiment of the present invention, the first seal molding 84 may bemade from titanium, stainless steel, any of a variety of plastics, anylong term implantable material, and the like.

The second seal recess 86 provides an insertion area for the extrusion74 of the first tubular member 52. The interface between the second sealrecess 86 and the extrusion 74 of the first tubular member 52 will bedescribed in greater detail below.

The second seal molding 72 may be made from a variety of bio-compatible,bio-stable, implantable grade materials. For example, according to anembodiment of the present invention, the second seal molding 72 may bemade from TEFLON or other fluoropolymers, other long term implantablematerials, and the like. A ring 76 for providing an additional seal mayalso be seen in FIG. 7. A first tubing coil 100, described in greaterdetail below, may also be seen in FIG. 7.

FIG. 8 shows a cutaway side view of the first tubular member 52. Inaddition to the coupling 56, the first outer housing 58, the firstheader portion 60, the extrusion 74 and the loop assembly recess 78,FIG. 8 also shows a first inner housing 90, a first catheter tubing 69,an inner molding 96 and an extension recess 98. The first cathetertubing 69 includes, but is not limited to, a first outer lumen 92 and afirst inner lumen 94.

The first catheter tubing 69 may extend the entire length of the firsttubular member 52 and may terminate at an interior portion of thecoupling 56. In the embodiment of the invention shown in FIG. 8, thefirst outer lumen 92 and the first inner lumen 94 of the first cathetertubing 69 are concentric, as was the case with the second outer lumen 80and the second inner lumen 82 shown in FIG. 7. Also, and as was the casewith the second outer lumen 80 and the second inner lumen 82 shown inFIG. 7, the first outer lumen 92 and the first inner lumen 94 need notbe concentric, and may positioned otherwise adjacent to each other.

When the first tubular member 52 and the second tubular member 54 areremovably attached to one another, the first catheter tubing 69 may forma path, which may be a continuous path, with the second catheter tubing68. Thus, a fluid may pass through the entire length of the firsttubular member 52 and the second tubular member 54 via the firstcatheter tubing 69 and the second catheter tubing 68. In addition, thepath formed by the first catheter tubing 69 and the second cathetertubing 68 may be used for elements other than fluids. For example, forsome applications, a sensor and sensor wires may be positioned withinthe first inner lumen 94 and the second inner lumen 82.

In the embodiment of the invention shown in FIG. 8, the first innerhousing 90 may surround and seal the first catheter tubing 69. Inaddition, the inner molding 96 may be formed around the first cathetertubing 69 during manufacturing and may completely encircle the firstcatheter tubing 69. Thus, the inner molding 96 may provide a first sealfor the first catheter tubing 69. The inner molding 96 may be made froma variety of bio-compatible, bio-stable, implantable grade materials.For example, according to an embodiment of the present invention, theinner molding 96 may be made from titanium, stainless steel, any of avariety of plastics, any long term implantable material, and the like.

According to an embodiment of the present invention, the extensionrecess 98 may provide an insertion area for the second seal molding 72of the second tubular member 54. The interface between the extensionrecess 98 and the second seal molding 72 of the second tubular member 54will be described in greater detail below.

FIG. 9 shows anchoring mechanisms for the first catheter tubing 69 andthe second catheter tubing 68 according to an embodiment of the presentinvention. In FIG. 9, a first tubing coil 100 and a second tubing coil102 may surround a portion of the outer diameters of the first cathetertubing 69 and the second catheter tubing 68, respectively. The first andsecond tubing coils 100 and 102 may engage the outer diameters of thefirst catheter tubing 69 and the second catheter tubing 68,respectively, to maintain the position of each catheter tubing withinrespect to the tubing coils.

According to an embodiment of the present invention, the first andsecond tubing coils 100 and 102 may be frictionally connected to thefirst catheter tubing 69 and the second catheter tubing 68. Thus, in theembodiment of the invention shown in FIG. 9, a “tubing-to-tubing”connection may be made without internal support mechanisms, such as aclamp, for example.

If the first and second tubing coils 100 and 102 are twisted such thatan inner diameter of each tubing coil increases, a catheter tubing maybe inserted into each tubing coil 100 and 102. However, if the innerdiameters of the tubing coils 100 and 102 are sized slightly smallerthan the outer diameter of the first catheter tubing 69 and the secondcatheter tubing 68, such as a few thousandths of an inch, for example,the inner diameters of the first and second tubing coils 100 and 102 maygrip the outer diameters of the first catheter tubing 69 and the secondcatheter tubing 68, respectively, when the first and second tubing coils100 and 102 are released and not twisted. Thus, the “anchor points” forthe first and second tubing coils 100 and 102 are transverse across thelength of the first catheter tubing 69 and the second catheter tubing68, respectively, rather than around the diameters of each tubing.Moreover, the load is distributed through each ring of the tubing coils.

If the first molding 104 and the second molding 106 are threaded withthe same pitch as the tubing coils 100 and 102, the first cathetertubing 69 and the second catheter tubing 68 may be rotatably insertedinto the moldings for placement. According to embodiments of the presentinvention, the tubing coils 100 and 102 may be glued into place. Also,the first and second tubing coils 100 and 102 may be designed such thatthe force exerted by the first and second tubing coils 100 and 102 onthe first catheter tubing 69 and the second catheter tubing 68,respectively, is great enough to maintain the position of the firstcatheter tubing 69 and the second catheter tubing 68 with respect to thefirst and second tubing coils 100 and 102 but not so great that theinner diameters of the first catheter tubing 69 and the second cathetertubing 68 are deformed or altered in any way.

The first and second tubing coils 100 and 102 may be fabricated in avariety of ways. For example, according to embodiments of the presentinvention, the first and second tubing coils 100 and 102 may be springs.According to other embodiments of the present invention, the first andsecond tubing coils 100 and 102 may be threads, rings with clips, squaresprings, round springs, splines, wires wrapped as coils and the like.Also, the first and second tubing coils 100 and 102 may be designed as a“Chinese” tube, where the inner diameter of the coil decreases as thetube is “stretched.” The first and second tubing coils 100 and 102 maybe made from stainless steel, alloys and the like.

FIG. 10 shows a perspective cutaway view of the interface between thefirst tubular member 52 and the second tubular member 54 when the firsttubular member 52 and the second tubular member 54 are removablyattached to one another. According to the embodiment of the inventionshown in FIG. 10, as the first tubular member 52 and the second tubularmember 54 engage each other, the extension recess 98, which may bethought of as a hollow interior portion of the extrusion 74, extendsover the second seal molding 72 of the second tubular member 54. Inaddition, the extrusion 74 of the first tubular member 52 may extendinto the second seal recess 86 of the second tubular member 54.According to an embodiment of the present invention, the extensionrecess 98 engages the second seal molding 72 and the extrusion 74engages the second seal recess 86 by compression or friction fit. Othertypes of engagement schemes may also be used. For example, according toan embodiment of the present invention, a locking mechanism may be usedto removably attach the first tubular member 52 to the second tubularmember 54.

Thus, as can be seen in FIG. 10, a first seal may be formed between thefirst seal molding 84 and the second outer lumen 80 when the firsttubular member 52 and the second tubular member 54 are removablyattached to one another. The first seal molding 84 may encircle thesecond outer lumen 80 and the second inner lumen 82. In addition, asecond seal may be formed when the second seal molding 72 engages thesecond header portion 64. Thus, the second seal may completely encirclethe first seal and the second outer lumen 80 and the second inner lumen82. Thus, according to the embodiment of the invention shown in FIG. 10,dual concentric seals surround and encircle the second outer lumen 80and the second inner lumen 82, thereby ensuring that any fluids passingthrough the second catheter tubing 68 and the first catheter tubing 69are confined to the interior portion of the modular catheter system 50.This allows the modular catheter system 50 to be fabricated with twoparts, a first tubular member 52 and a second tubular member 54, thatare removably attached to one another, without concern that fluidstransported through the second catheter tubing 68 and the first cathetertubing 69 will leak into the area surrounding the catheter system 50,which is typically implanted into a human body.

It can also be seen in FIG. 10 that, when the first tubular member 52and the second tubular member 54 are removably attached to one another,the first header portion of the first tubular member 52 may abut thedisc 62 of the second tubular member 54, providing a stable interfacebetween the first tubular member 52 and the second tubular member 54. Inaddition, the second header portion 64 may surround and completelyencircle the second seal molding 72, providing yet another seal. Thus,in the embodiment of the invention shown in FIG. 10, three concentricseals have been formed. A first seal may be formed at the interfacebetween the first seal molding 84 and the second outer lumen 80, asecond seal may be formed between the second seal molding and the firstseal molding 84, and a third seal may be formed between the second sealmolding 72 and the second header portion 64, all of which areconcentric. However, embodiments of the invention may be configured tohave any number of concentric seals.

FIG. 11 shows a cutaway view of a compression fit interface between afirst tubular member 52 and a second tubular member 54 when the firsttubular member 52 and the second tubular member 54 are removablyattached to one another according to an embodiment of the presentinvention. According to the embodiment of the invention shown in FIG.11, as the first tubular member 52 and the second tubular member 54engage each other, the extension recess 98, which may be thought of as ahollow interior portion of the extrusion 74, extends over the secondseal molding 72 of the second tubular member 54. In addition, theextrusion 74 of the first tubular member 52 may extend into the secondseal recess 86 of the second tubular member 54. According to theembodiment of the present invention shown in FIG. 11, the extensionrecess 98 engages the second seal molding 72 and the extrusion 74engages the second seal recess 86 by compression. Thus, the firsttubular member 52 and the second tubular member may connect to oneanother via compression fit.

FIG. 12 shows a perspective, cutaway view of the compression fitinterface shown in FIG. 11. In FIG. 12, the second tubular member 54 isshown. The second seal molding 72 may be seen disposed adjacent thesecond seal recess 86.

The modular catheter system according to embodiments of the presentinvention has a variety of advantages over catheter systems of the priorart. In addition to reducing the risk of infection and minimizing traumato the patient, portions of the modular catheter system that attach toimplantable devices, such as the first tubular member, for example, thatremain implanted for relatively long periods of time, may be fabricatedwith expensive components that will remain implanted. Inexpensivecomponents may be placed in a removable portion of the modular cathetersystem, such as the second tubular member, for example. Thus, removingand replacing the removable portion of the modular catheter systembecomes cost effective.

In addition, because embodiments of the invention may be fabricatedusing TEFLON or other fluoropolymers, which have a higher meltingtemperature than polyethylene, as an inner layer of the catheter tubing,the modular catheter system may be sterilized by autoclaving rather thanEtO. As is well-known in the art, autoclaving is a less expensive methodof sterilizing than EtO, which further adds to a reduced cost whenpreparing the catheter system for utilization.

Also, because embodiments of the present invention include, but are notlimited to, a plurality of concentric seals, at least some of which areformed via a friction fit between at least two members, the pull forcerequired to separate the friction-fitted joints may be at least 2.0 lbs.In addition, due to the integrity of the plurality of concentric seals,at least some of which are formed via a friction fit between at leasttwo members, fluid may be passed through the catheter system at up to200 psi and higher.

While particular embodiments of the present invention have been shownand described, it will be obvious to those skilled in the art that theinvention is not limited to the particular embodiments shown anddescribed and that changes and modifications may be made withoutdeparting from the spirit and scope of the appended claims.

1. A modular catheter system comprising: a first tubular member; a firstcatheter tubing, the first catheter tubing disposed within an interiorportion of the first tubular member; a second tubular member, the secondtubular member being removably attachable to the first tubular member;and a second catheter tubing, the second catheter tubing disposed withinan interior portion of the second tubular member, wherein the firstcatheter tubing and the second catheter tubing form a continuous pathwhen the first tubular member is removably attached to the secondtubular member.
 2. The modular catheter system according to claim 1,further comprising a plurality of concentric seals surrounding at leasta portion of the first catheter tubing and the second catheter tubing.3. The modular catheter system according to claim 2, wherein at leastone of the plurality of concentric seals is formed when the secondtubular member is removably attached to the first tubular member.
 4. Themodular catheter system according to claim 1, wherein the first tubularmember forms an angle with the second tubular member when the secondtubular member is removably attached to the first tubular member.
 5. Themodular catheter system according to claim 4, wherein the angle formedbetween the first tubular member and the second tubular member issubstantially a right angle.
 6. The modular catheter system according toclaim 1, further comprising a first coil surrounding at least a portionof the first catheter tubing; and a second coil surrounding at least aportion of the second catheter tubing, wherein the first coil maintainsa position of first catheter tubing and the second coil maintains aposition of second catheter tubing.
 7. The modular catheter systemaccording to claim 6, wherein the first coil and the second coil aresprings.
 8. The modular catheter system according to claim 3, furthercomprising: a third catheter tubing, the third catheter tubing disposedwithin an interior portion of the first tubular member and adjacent thefirst catheter tubing; and a fourth catheter tubing, the fourth cathetertubing disposed within an interior portion of the second tubular memberand adjacent the second catheter tubing, wherein the third cathetertubing and the fourth catheter tubing form a continuous path when thesecond tubular member is removably attached to the first tubular member.9. The modular catheter system according to claim 8, wherein the firstcatheter tubing is concentric with the third catheter tubing and thesecond catheter tubing is concentric with the fourth catheter tubing.10. The modular catheter system according to claim 8, wherein at leastone of the plurality of concentric seals formed when the second tubularmember is removably attached to the first tubular member encircles thethird catheter tubing and the fourth catheter tubing.
 11. The modularcatheter system according to claim 1, wherein the first tubular memberincludes an extrusion and the second tubular member includes a recess.12. The modular catheter system according to claim 11, wherein theextrusion of the first tubular member fits into the recess of the secondtubular member via friction.
 13. The modular catheter system accordingto claim 11, wherein the extrusion of the first tubular member fits intothe recess of the second tubular member via compression.
 14. The modularcatheter system according to claim 1, wherein the first catheter tubingis a fluoropolymer.
 15. The modular catheter system according to claim12, wherein at least one of the plurality of concentric seals istitanium.
 16. The modular catheter system according to claim 15, whereinthe at least one titanium concentric seal abuts and encircles thefluoropolymer first catheter tubing.
 17. The modular catheter systemaccording to claim 16, wherein the first tubular member and the secondtubular member are silicone.
 18. The modular catheter system accordingto claim 17, wherein the silicone first tubular member and the siliconesecond tubular member abut and encircle at least one titanium concentricseal.
 19. The modular catheter system according to claim 1, furthercomprising an anchoring portion at a proximal end of the second tubularmember, wherein a proximal end of the first tubular member abuts theanchoring portion of the second tubular member when the first tubularmember is removably attached to the second tubular member.
 20. Themodular catheter system according to claim 19, further comprising acoupling disposed at a distal end of the first tubular member, whereinthe coupling is attachable to an implantable device, and wherein thesecond catheter tubing extends out of the second tubular member.
 21. Themodular catheter system according to claim 20, further comprising asensor disposed within an interior portion of the second tubular member.22. An implantable catheter comprising: a housing, the housing having aremovably attachable interface; a first tubing, the first tubingdisposed within an interior portion of the housing; and a plurality ofconcentric seals disposed within the housing and encircling the firsttubing.
 23. The implantable catheter according to claim 22, wherein atleast one of the plurality of concentric seals is formed when theremovably attachable interface is engaged by a peripheral device. 24.The implantable catheter according to claim 22, further comprising asecond tubing disposed within an interior portion of the housing andadjacent the first tubing.
 25. The implantable catheter according toclaim 24, wherein the first tubing and the second tubing are concentric.26. The implantable catheter according to claim 22, wherein the firsttubing is a fluoropolymer.
 27. The implantable catheter according toclaim 26, wherein at least one of the plurality of concentric seals istitanium.
 28. The implantable catheter according to claim 27, whereinthe at least one titanium concentric seal abuts and encircles thefluoropolymer first tubing.
 29. The implantable catheter according toclaim 27, wherein the housing abuts and encircles the at least onetitanium concentric seal.
 30. The implantable catheter according toclaim 22, wherein the housing is plastic.
 31. The implantable catheteraccording to claim 22, wherein the housing is silicone.
 32. A method ofimplementing a catheter comprising: providing a first outer housing;providing at least one first lumen tubing, the at least one first lumentubing being disposed within an interior portion of the first outerhousing; sealing the at least one first lumen tubing with a first seal;and sealing the at least one first lumen tubing with a second seal,wherein the first seal and the second seal are concentric, and whereinthe first seal and the second seal encircle the at least one first lumentubing.
 33. The method of claim 32, further comprising: providing asecond housing; and providing at least one second lumen tubing, whereinthe second housing is removably attachable to the first housing, whereinthe at least one second lumen tubing forms a path with the at least onefirst lumen tubing when the second housing is removably attached to thefirst lumen housing, and wherein at least one of the first seal and thesecond seal is formed when the second housing is removably attached tothe first housing.
 34. The method of claim 32, further comprising:providing at least one third lumen tubing adjacent the at least onefirst lumen tubing; and providing at least one fourth lumen tubingadjacent the at least one second lumen tubing.
 35. The method of claim34, wherein the at least one third lumen tubing is concentric with theat least one first lumen tubing, and wherein the at least one fourthlumen tubing is concentric with the at least one second lumen tubing.